Clinical trial · Observational
Observational Study to Evaluate the Safety and Efficacy of Zepzelca™ Injection
Observational Study to Evaluate the Safety and Efficacy of Zepzelca™ Injection (Lurbinectedin) in Patients With Metastatic Small Cell Lung Cancer (SCLC) in Real-World Practice
NCT06021483CI-TRIAL-00095241recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to evaluate the safety and efficacy of Zepzelca™ inj. in real-world practice and to investigate important identified risks and gaps in information related to risk management plans.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| SCLC | Lung Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- ORR (Overall Response Rate)
- timeFrame
- 6 months after the start of administration
- description
- Percentage of subjects who reached complete remission (CR) and partial remission (PR)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
Show eligibility criteria text
Inclusion Criteria: * Patients who voluntarily provide written consent for personal information collection and utilization after receiving an explanation about the objective and methods of the study * Patients who have received or are scheduled to receive Zepzelca™ inj., according to domestic approval indications * Patients with metastatic SCLC who have failed first-line platinum-based chemotherapy Exclusion Criteria: * Patients with no prior history of platinum-based anticancer chemotherapy for cancer treatment * Patients with a history of hypersensitivity reactions to this drug or its components * Pregnant, potentially pregnant, or lactating women * Patients currently participating in another clinical trial (drug or medical device) or planning to participate in another clinical trial during the study period (except for non-interventional clinical studies or cases where the clinical trial drug administration has ended and only follow-up is remaining) * Patients who are judged by the principle Investigator or sub-Investigator to be ineligible to participate in the study.
References
Publications (0)
Data not yet available
No reference posted for this study.